Kornimate/medical-research-clean huggingface dataset:
a study to evaluate safety, tolerability and pharmacokinetics of mknd-201 in healthy volunteers

Conditions: Healthy Volunteers

Summary: mkc-ni-001 is a phase 1, first-in-human, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (mnkd-201) in healthy adult volunteers. the trial consists of a single ascending dose (sad), followed by a multiple ascending dose (mad) with a primary objective to evaluate the safety, tolerability, and pharmacokinetics (pk) of mnkd-201 compared to placebo in healthy adult participants.


Eligibility criteria:
key inclusion criteria: * is ≥40 and ≤65 years of age at the time of signing the informed consent form. * has a negative urine test for selected drugs of abuse and negative alcohol test at screening and upon admission to the cru on day -1. note: participants should not consume poppy seeds within 24 hours before urine drug screening because this can falsify the results of the opiate urine drug test. * is willing to adhere to the restrictions and requirements specified in the protocol. * has a negative severe acute respiratory syndrome coronavirus 2 (sars-cov-2) test (i.e., the virus that causes covid-19) on day -1. * is capable of performing spirometry, as required by the study procedures. key exclusion criteria: * has a history of significant lung disease (e.g., pulmonary fibrosis, cystic fibrosis, copd, emphysema, chronic pulmonary infection, recent upper or lower respiratory tract infection in the prior 8 weeks, history of lung surgery or procedure, etc.) * has endocrine, thyroid, or respiratory disease, diabetes mellitus, coronary heart disease, gi disease, or history of any psychotic mental illness. * has a history of hepatic disease or has abnormal liver function tests (i.e., aspartate aminotransferase \[ast\] \> 1.5 × upper limit of normal \[uln\] or alanine aminotransferase \[alt\] \> 1.5 × uln) at screening. * has renal impairment (estimated glomerular filtration rate \[egfr\] \< 60 ml/min/1.73 m2), as calculated by chronic kidney disease epidemiology collaboration (ckd-epi), at screening. * has any history of pulmonary malignancy. * has a history of substance abuse or dependency or history of recreational drug use over the last 2 years (by self-declaration).
correlation of genetic susceptibility genes to inflammatory bowel disease in chinese han population

Conditions: Gene Abnormality; Inflammatory Bowel Disease; Chinese

Summary: the pathogenesis of ibd is still unclear, and the disease characteristics of ibd patients are affected by genetic susceptibility genes. therefore, this study aims to explore the relationship between genetic susceptibility genes of ibd and the pathogenesis of ibd in chinese han population, in order to clarify the pathogenesis of ibd and provide basis for individualized treatment of ibd.

the pathogenesis of ibd is still unclear, and the disease characteristics of ibd patients are affected by genetic susceptibility genes. therefore, this study aims to explore the relationship between genetic susceptibility genes of ibd and the pathogenesis of ibd in han chinese, in order to clarify the pathogenesis of ibd and provide basis for individualized treatment of ibd.in this study, 5ml peripheral venous blood was drawn from ibd patients and normal controls for gene testing.to investigate the relationship between polymorphisms of trail, itga4, icam1, itga4, icam1, lta, fcgr3a, trap1, tnfrsf1b, cdkn2b-as1 and susceptibility to ibd in chinese han population.

Eligibility criteria:
inclusion criteria: * confirmed ibd patients were collected from the department of gastroenterology, the second affiliated hospital of wenzhou medical university.according to the consensus of "diagnosis and treatment of inflammatory bowel disease" formulated by chinese society of gastroenterology, the diagnosis of ibd was established by clinical, laboratory, radiographic, digestive endoscopy and histopathological examination.during the same period, 476 healthy subjects were collected from the physical examination center of our hospital as the normal control group exclusion criteria: * active infection, malignant tumor, congestive heart failure, demyelination of nervous system, allergy to rat derived protein components, etc all subjects were excluded from infectious diarrhea, ischemic enteropathy, radiation enteritis, gastrointestinal tumor, diabetes, systemic lupus erythematosus, rheumatoid arthritis and autoimmune thyroiditis by clinical examination before inclusion.

Keywords: ibd;gene;chinese han population
cross-sectional study to assess prevalence and burden of ckd-associated pruritus in hemodialysis patients

Conditions: Chronic Kidney Disease-associated Pruritus

Summary: vifor international ltd. is seeking real-world evidence (rwe) to better understand the epidemiology, patient characteristics, and management of ckd-ap in the real-world clinical setting.

ckd-ap is a global clinical problem, and finding effective treatment remains a therapeutic challenge because of its complex pathophysiology (sommer 2007, weisshaar 2019, yosipovitch 2013). the association between ckd-ap and clinical features and laboratory data remains unclear (davison 2021, manenti 2021). ckd-ap is thought to be associated with several conditions, including vitamin d deficiency, metabolic abnormalities (e.g., abnormal serum calcium or phosphate levels), toxin build-up, peripheral neuropathy, immune system dysregulation, or opioid receptor dysregulation (jung 2015, xie 2021, kremer 2019, verduzco 2020, swarna 2019, manenti 2021). at present, there is no systematic assessment of ckd-ap in routine clinical practice, and the prevalence of ckd-ap is generally under-reported by patients and therefore underestimated by as much as 69% of healthcare professionals (hcps) (rayner 2017). alleviating the burden of ckd-ap requires proactive identification of patients who suffer from it (sukul 2020, davison 2015, phan 2012).

Eligibility criteria:
inclusion criteria: * male or female adult patients with ckd (≥18 years) receiving hd for at least 3 months prior to signing informed consent * signed informed consent * able and willing to fill in questionnaires exclusion criteria: * patients receiving hd at home or both home and site

Keywords: ckd ckd-ap ckd associated pruritus
efficacy and safety of the rivastigmine transdermal patch in patients with probable alzheimer's disease

Conditions: Alzheimer's Disease; Dementia, Alzheimer Type

Summary: the goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable alzheimer's disease.


Eligibility criteria:
inclusion criteria: * diagnosis of dementia of the alzheimer's type * males, and females who are surgically sterile or one year postmenopausal * a primary caregiver willing to accept responsibility for supervising the treatment exclusion criteria: * any condition (other than alzheimer's) that could explain patient's dementia * an advanced, severe or unstable disease that may put the patient at special risk * current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease

Keywords: alzheimer's disease dementia
comparison of the analgesic effect of different local anesthetics in interscalene nerve block for shoulder surgery

Conditions: Other Peripheral Nerve Disease

Summary: several reports have compared the duration of action of levobupivacaine and ropivacaine as local anesthetic. the most widely used method for sensory function evaluation is though means of a pinprick test. the investigators want to use the novel method of quantitative sensory testing to better evaluate the anesthetic activity. this method used hot and cold sensation to assess small nerve fiber function. the investigators will assess the duration of action of different drugs when used in an inter scalene nerve block in patients scheduled for shoulder surgery.

this study aims to compare the length of the analgesic effect of different local anesthesic solutions, used in an interscalene nerve block. this will be objectified by measuring the changes in small nerve functioning, using quantative sensory testing. based on the results of a previous study, the investigators reduce the dose of the administered local anesthetic, expecting a similar length of action using these smaller doses.

Eligibility criteria:
inclusion criteria: * american society of anesthesia class i or ii * scheduled for shoulder surgery exclusion criteria: * mental retardation * allergy for local anesthetics * nsaid intolerance or contraindicated * diabetes mellitus * chronic use of pain killers

Keywords: peripheral nerve block
the effect of dry needling on trunk muscle function in low back pain patients

Conditions: Low Back Pain

Summary: the study will establish data on the function of trunk muscles in healthy and low back pain patient's pre and post dry needling treatment. this will help in understanding the underlying mechanism of this treatment and reveal the effect of dry needling on muscle performance. study hypothesis is that an improvement of back muscle function following dry needling procedure will be found.

dry needling of muscles is mainly used for the management of pain in musculoskeletal disorders. yet, the association between dry needling and motor performance of muscles is still unclear. this study aims to investigate the immediate effect of dry needling on lumbar multifidus muscles' function in healthy and low back pain subjects. the sample will be divided into: low back pain group and control (healthy) group. both groups will receive dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine). the needles will be left in situ for 10 minutes. ultrasound imaging will be used to measure multifidus muscles' thickness, pre and post- procedure during rest in a prone position and during contralateral active straight leg extension.

Eligibility criteria:
inclusion criteria: * age: 18-60 years. * healthy individuals or individuals with main complaint of low back pain (lbp) exclusion criteria: * patients with "red flags" for a serious spinal condition, for example: tumor, compression fractures, infection, cancer. * signs of nerve root compression (positive straight leg raise \<45 degrees, decreased reflexes, decrease sensation or decreased strength in the lower extremities). * pregnancy. * previous surgery to the lumbar spine * history of congenital lumbar or pelvic anomalies * physical therapy for lbp was provided in the 6 months prior to participation in the study * patients who are unable to lie prone for 30 minutes.

Keywords: ultrasound imaging acupuncture back muscles spine muscle strength
sglt-2 and dpp-4 inhibition, subclinical inflammation of the genito-urinary tract and risk of infections.

Conditions: Type 2 Diabetes; Urinary Tract Infections

Summary: in this observational study, 60 subjects with type 2 diabetes (t2d) and eligible, as per good clinical practice, for therapy with sglt-2 inhibitor, will be randomized to receive a sglt-2 inhibitor or a fixed dose combination of sglt-2 inhibitor with a dpp4-inihibitor for 12 weeks. measures will be performed at baseline and after 12 weeks of treatment, as per good clinical practice.

the day of the study patients undergo a routine clinical evaluation. whole blood samples will be collected from an antecubital vein to assess serum/plasma aliquots of 200 μl each (frozen at -80°c until required for quantitation) for evaluation of biochemical parameters (fasting glucose, hba1c, lipid profile, serum creatinine, uric acid, electrolytes, liver function enzymes, albumin). a mid-stream first urine in the morning sample will be collected into a sterile container. 50 ml of urine will be immediately transferred into a sterile falcon and centrifugated at 4500 rpm for 10 min. after removal of the supernatant and addition of 10 ml of pbs or sterile physiological solution, the sample will be further centrifugated at 4500 rpm for 10 min. the supernatant will be removed and the pellet stored in a falcon at -80°c. genomic dna will be extracted throw qiamp dna mini kit (qiagen) and quantified using spectrophotometric assay.

Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosis * hb1ac ≥ 7% and ≤ 9% exclusion criteria: * hb1ac \> 9% * current treatment with an sglt2i or a dpp4i drugs, or in the prior 4 week * irritating and/or obstructive urinary or genital symptoms * menstrual cycle for women * current antibiotic treatment or in the prior 4 weeks * anatomical or functional abnormalities of the urinary tract (e.g. incontinence, neurological bladder, bladder prolapse).

Keywords: uti type 2 diabetes sglt2 inhibitors dpp4 inhibitors
collaborative systematic overview of randomised controlled trials of beta-blockers in the treatment of heart failure

Conditions: Heart Failure

Summary: several large trials have shown that beta-blocker treatment reduces the risk of death and hospital admission in patients with symptomatic heart failure. unfortunately, survey data suggests relatively poor utilisation of beta-blockers, despite ample evidence for good tolerability. additionally there are several important unanswered questions, such as clinical efficacy for specific sub-populations (women, the elderly and patients with diabetes or other co-morbidities) and the effect of beta-blockers in combination with other medications. previous meta-analyses, based on published tabular data, have been conducted although this approach has important biases and limitations. we plan to perform a carefully conducted systematic review of individual patient data from the major randomised trials of beta-blockers in heart failure. the goals of this collaborative project are to clarify the overall efficacy of beta-blockers and identify sub-groups that show particular benefit, thereby increasing the use of beta-blockers, reducing adverse clinical outcomes and the high costs associated with this condition.


Eligibility criteria:
inclusion criteria: * randomised control trials of beta-blocker versus control in patients with documented heart failure * unconfounded trials only (in which one treatment group differed from another only by the beta-blocker therapy of interest) * randomization process precluded prior knowledge of the next treatment (for example trials in which treatment allocation was alternate or based on odd or even dates would not be included) exclusion criteria: * trial sample size of less than 300 patients

Keywords: beta blocker heart failure meta analysis individual patient data
prospective validation of a points score system predicting 30-day survival

Conditions: Metastatic Cancer

Summary: this is a one-stage single-arm phase ii clinical trial designed to prospectively test the survival prediction tool as developed by lee et al on patients referred to radiation oncology for palliative treatments. survival prediction score based on objective data including laboratory values, attendance to emergency room, and primary cancer origin will be assigned to each patient at time of enrollment.

this is a one-stage single-arm phase ii clinical trial designed to prospectively test the survival prediction tool as developed by lee et al (section 10.0) on patients referred to radiation oncology for palliative treatments. survival prediction score based on objective data including laboratory values, visits to emergency room, and primary cancer origin will be assigned to each patient at time of enrollment. the prediction tool assigns a score from 0-20, with 20 indicating the worst survival prognosis; the investigators have designated mortality risk groups as follows: low-risk (score 0-6), intermediate-risk (score 7-13), and high-risk (score 14-20). patient survival and quality of life will then be monitored at 30-day, 90-day, and 365-day intervals. the study will test the hypothesis that patients with a score of \>14 have a less than 20% chance of survival at 30 days. primary objective: 1. to evaluate 30-day survival of patients with a score of \>14 (high-risk group) secondary objectives: 1. to evaluate 30-day, 90-day, and 365-day survival of patients in low-risk (score 0-6), and intermediate-risk (score 7-13) groups, and to evaluate 90-day and 365-day survival of patients in high-risk group (score \>14) 2. to evaluate patient-reported quality of life at the above intervals using the validated facit-pal-14© questionnaire (functional assessment of chronic illness therapy - palliative care 14 item version)

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 at time of consent 2. ability to provide written informed consent 3. cancer diagnosis referred to radiation oncology for palliative radiation therapy 4. patients who either choose to not receive radiation therapy or not recommended to receive radiation therapy will remain eligible 5. those patients who undergo a course of palliative radiation therapy, it is not the requirement of this study to complete that course of treatment. those who prematurely end their course of treatment will remain eligible note: patients who ultimately either choose to not receive radiation or not recommended to receive radiation will remain eligible note: patients who ultimately do not complete prescribed radiation will remain eligible exclusion criteria: 1. patients who are unable to participate in follow up visits per investigator discretion (virtual/phone follow up is permitted) 2. patients who are receiving definitive/curative course of radiation therapy 3. patients who self-report as pregnant or nursing

Keywords: palliative radiation radiation therapy
suprascapular nerve block efficacy for shoulder surgery

Conditions: Shoulder Pain; Postoperative Pain; Rotator Cuff Tears; Anesthesia; Anesthesia, Local

Summary: this study evaluates the analgesia induced by suprascapular nerve block in comparison to interscalene nerve block in arthroscopic rotator cuff repairs. the experimental and the control group will receive the suprascapular nerve block and interscalene nerve block, respectively.

peripheral nerve blocks are widely used for postsurgical analgesia. interscalene nerve block provides a total brachial plexus motor and sensitive blockade while the suprascapular nerve block produces only a specific peripheral blockade. the interscalene nerve block is the most frequently used anesthesia technique and requires a longer learning curve. complications related to this technique may be more severe and frequent in comparison to other regional anesthesia techniques. the suprascapular nerve block yields less adverse effects, discomfort and rebound effect as this technique does not completely block the upper limb motor function.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years old * confirmed rotator cuff tear by magnetic resonance imaging exclusion criteria: * irreparable cuff tears (retracted lesions to the glenoid rim and/or fourth grade fatty infiltration) * partial repair of cuff tears (immobile lesions) * rheumatic diseases * neck-related shoulder pain * glenohumeral instability or osteoarthritis

Keywords: shoulder surgery pain brachial plexus blockage anesthesia interscalene blockage opioid
study to assess enobosarm (gtx-024) in postmenopausal women with stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: gtx-024 is an orally bioavailable and tissue-selective nonsteroidal selective androgen receptor modulator (sarm) that has demonstrated androgenic and anabolic activity and is currently being evaluated as a potential treatment for stress urinary incontinence (sui) in postmenopausal women. urinary incontinence and pelvic floor disorders are major health problems for women, especially as they age. pelvic floor muscle relaxation has been found to correlate with lower urinary tract symptoms including sui. muscles of the pelvic floor and lower urinary tract are crucial for supporting the pelvic organs and micturition; however, damage to the muscles or lack of hormonal stimulation are thought to contribute to pelvic organ prolapse and urinary incontinence. although anabolic steroids may increase muscle mass and strength, lack of oral bioavailability and known potential risks have limited their use. nonsteroidal sarms have potential to achieve benefits of anabolic steroid therapy (improved muscle mass, cholesterol/triglyceride levels, glucose metabolism, and bone density) with fewer adverse effects, such as hirsutism and acne, in women. both nonclinical and clinical data suggest that sarms may provide a new therapeutic option for pelvic floor and lower urinary tract disorders, as both testosterone and its more potent metabolite, dihydrotestosterone, have anabolic effects on muscle.


Eligibility criteria:
key inclusion criteria: * sui symptoms of at least 6 months duration * predominant sui as determined at the screening visit using the medical, epidemiological, and social aspects of aging (mesa) urinary questionnaire. * 24-hour pad weight \> 3 g during the screening period * a minimum of 1 and no more than 15 sui episodes on any single day and no fewer than 9 total sui episodes over 3 days during the screening period * positive bladder stress test conducted during the screening visit key exclusion criteria: * history of pelvic radiation treatment * history of urethral diverticula * history of urethral sling or anterior prolapse repair * treatment with urethral bulking agents and/or other sui procedure or surgery within the 6 months prior to the screening visit * known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities * urinary incontinence of neurogenic etiology * morbidly obese (defined as 100 pounds over ideal body weight, or body mass index 40 or greater) * chronic hepatitis * hepatic cirrhosis * evidence of active infection with hepatitis b or hepatitis c * history of human immunodeficiency virus (hiv) infection * subjects with a history of breast or endometrial cancer
clinical study on third-line treatment of advanced duodenal adenocarcinoma by fuquinitinib combined with sindillimab

Conditions: Third-line Treatment; Dvanced Duodenal Adenocarcinoma; Furquinelone Combined With Sintilimab

Summary: this research project is a single-center, retrospective clinical exploration study. it aims to retrospectively analyze data from 20 patients with advanced duodenal adenocarcinoma who received third-line treatment with furquinelone combined with sintilimab, in order to determine the clinical efficacy and safety of this combination therapy in advanced duodenal cancer.


Eligibility criteria:
inclusion criteria: * patients must meet all of the following criteria to be eligible for inclusion: age between 18 and 80 years (inclusive); imaging findings consistent with unresectable local advanced, recurrent or metastatic duodenal adenocarcinoma; histologically confirmed unresectable local advanced, recurrent or metastatic duodenal adenocarcinoma; ecog performance status 0-2; at least one measurable or evaluable lesion according to recist v1.1; third-line or above treatment with the combination of sintilimab and furquimatinib. exclusion criteria: - patients meeting any of the following criteria will be excluded: patients with incomplete clinical data or laboratory examination that affects statistical analysis; patients who have had other malignant tumors in the past 5 years; patients who have had arterial thrombotic diseases such as angina, myocardial infarction, and transient ischemic attack in the past 6 months; patients who have received other types of anti-tumor or experimental treatment; pregnant or lactating women; patients with other diseases or abnormal mental status that may affect the patient's treatment; patients who have received other types of immune therapy, anti-angiogenic drugs, or small-molecule tyrosine kinase inhibitors.